Business case - HxGN EAM - 12.00.00 - Feature Briefs - Hexagon

HxGN EAM Calibrations

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There are many types of businesses in which tight control over processes is desired or required. For example, healthcare companies that produce intravenous solutions (IV) solutions must control and monitor processes that are used to heat seal the PVC solution bags, as well as the processes used to sterilize full solution bags prior to packing and shipping. The correct temperature and pressure are critical to delivering a quality bag of IV solution.

In this case, the FDA and EMA both high regulate these aspects of IV solution production, among other processes. If the solutions manufacturer does not adhere to these requirements, they are subject to serious fines, temporary shutdowns, and, facility closure. There are also the potential losses associated with liability and types of legal damages.

These companies must prove to the FDA or EMA that they have repeatable processes capable of operating within the specified limits for production. Besides taking periodic measurements for temperature and pressure, while in production, recording them, and archiving this data, companies also require that device/processes involved in creating/maintaining these characteristics be calibrated periodically to ensure repeatability within the desired ranges.

This is just one example of where calibration would be required. There are others, for example, the oil/gas, chemical, automotive, and food industries all require proper calibration of devices and processes. In addition, are different regulatory authorities that ensure this is done.